FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LTM-RC SURGICAL MESH
K Number: K071986
·
Decision Oct 19, 2007
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
162
Applicant Total
10
Review Days
91
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Basic Information
- Device Name
- LTM-RC SURGICAL MESH
- K Number
- K071986
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lifecell Corp.
- Date Received
- July 20, 2007
- Decision Date
- October 19, 2007
- Product Code
- FTM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FTM | Mesh, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Lifecell Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K130817 | LTN - LAPAROSCOPIC SURGICAL MESH | Apr 17, 2013 | Substantially Equivalent |
| K112534 | LIFECELL TISSUE EXPANDER | Aug 10, 2012 | Substantially Equivalent |
| K121289 | LTM-LABAROSCOPIC SURGICAL MESH | Aug 3, 2012 | Substantially Equivalent |
| K082176 | LTM-BPS SURGICAL MESH | Nov 14, 2008 | Substantially Equivalent |
| K082103 | LTM WOUND DRESSING | Oct 8, 2008 | Substantially Equivalent |
| K080353 | LTM-T SURGICAL MESH | Apr 3, 2008 | Substantially Equivalent |
| K070560 | LRTM SURGICAL MESH | Jun 11, 2007 | Substantially Equivalent |
| K061208 | LIFECELL DURAL SUBSTITUTE MATRIX | Jan 3, 2007 | Substantially Equivalent |
| K052735 | ALLOCRAFT DBM | Dec 28, 2005 | Substantially Equivalent |